Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00353860
Eligibility Criteria:
* INCLUSION CRITERIA - PATIENT:
Ages 10-55 years inclusive (but less than 56).
Chronic myelogenous leukemia in chronic phase
A) Patients not treated with STI 571 under the age of 41 (subject to regular DSMB review);
B) Age 10-55 in chronic phase who have failed treatment with STI-571;
C) Age 10-55 in accelerated phase or blast transformation.
Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in first remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second or subsequent remissions, primary induction failure, partially responding or untreated relapse.
Acute myelogenous leukemia (AML): AML in first remission except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse.
Myelodysplastic syndromes, any of these categories: refractory anemia with transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.
Myeloproliferative disorders (myelofibrosis, polycythemia vera, essential thrombocythemia) in transformation to acute leukemia.
Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000/microliters) or anemia (less than or equal to 10 g/dl) not due to recent chemotherapy.
No major organ dysfunction precluding transplantation.
DLCO greater than or equal to 60% predicted.
Left ventricular ejection fraction: greater than or equal to 40% predicted.
ECOG performance status of 0 or 1.
For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian. Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
Negative pregnancy test for women of childbearing age.
INCLUSION CRITERIA - DONORS:
HLA 6/6 identical family donor.
Weight greater than or equal to 18 kg.
Age less than or equal to 80 years old.
Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).
For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
EXCLUSION CRITERIA - RECIPIENT:
Patient pregnant.
Age less than 10 years and 56 years or more.
Patients with CML in chronic phase who are 41 years or over in whom STI 571 is the treatment of choice.
ECOG performance status of 2 or more.
Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
Major anticipated illness or organ failure incompatible with survival from BMT.
DLCO less than 60% predicted.
Left ventricular ejection fraction: less than 40% predicted.
Serum creatinine greater than 3 mg/dl.
Serum bilirubin greater than 4 mg/dl.
Transaminases greater than 3x upper limit of normal.
HIV positive.
History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.
Individuals with diseases listed in the inclusion criteria but where debility or age makes the risk of intensive myeloablative therapy unacceptable. This includes patients who have received busulfan treatment for more than 6 months continuously. These patients will be considered for non-myeloablative allogeneic transplantation protocols.
EXCLUSION CRITERIA - DONOR
Pregnant or lactating.
Donor unfit to receive G-CSF and undergo apheresis. (uncontrolled hypertension, history of congestive heart failure, or unstable angina, thrombocytopenia).
HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the risk-benefit ratio is considered acceptable by the patient and investigator.
Weight less than 18 kg.
Age greater than 80 years.
Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
80 Years
Study:
NCT00353860
Study Brief:
Protocol Section:
NCT00353860